National and international chemicals legislation and the wide range of applications for our additives result in a multitude of regulatory requirements.
If you have a specific regulatory question about one of our products, please feel free to contact us. Our product safety department will be happy to assist you in answering your questions.
In the following you will find some general information.
All our products and their ingredients are registered in the European Union (EU) according to REACh or are exempt from the REACh registration obligation. The products marketed in the USA and Canada are listed in the corresponding national chemical inventories (TSCA, DSL / NDSL).
An overview of the registration status is listed in our “Regulatory Information Sheets”, which we will be happy to send you on request.
Whether an additive is suitable for use in direct or indirect food contact applications depends on many different factors, including:
– the type of plastic/polymer,
– dosing and process parameters,
– the properties/type of food,
– contact temperature and contact time with the food,
– possible interactions with other additives,
– the relationship between packaging surface area and volume,
– compliance with migration limits.
Many of these factors are not known to us or cannot be tested by us. Therefore, we cannot guarantee the compliance of our product with the specific application of our customer. The final evaluation and compliance with the legal requirements is always the responsibility of the manufacturer of the final food contact material. For this purpose, we recommend our customers to make use of external expertise.
How we can support you…
In our “Food Contact Statements” we give you an overview of the information available to us. Here, for example, you can find out in which FDA paragraphs the ingredients of our product are listed by name or whether the ingredients are included in the EU list of European Regulation (EU) No. 10/2011. The information in the “Food Contact Statement” is based on our current state of knowledge at the time of writing, but we do not guarantee the accuracy or completeness of this information.
In addition, we are of course prepared to provide further details and exact information on the composition of our product to an external legal expert, consultant or testing institute commissioned by the customer under a confidentiality agreement. We are also happy to support you with contacts of companies with whom we have already cooperated successfully with in this regard in the past.
You cannot find a suitable additive for your food contact material and your application?
The listing of a specific FDA paragraph in our “Food Contact Statement” does not mean that the corresponding product can automatically be used for a specific application. On the other hand, the absence of a listing in an FDA paragraph does not mean that our product is unsuitable for your application and cannot be used in food contact applications!
Due to the limited selection of substances listed in the regulations of the FDA and the EU, we recommend our customers to consider products for first laboratory tests which are not listed in our “Food Contact Statement”. In this case, of course, products are primarily considered which appear to be harmless to health due to their classification. We would be pleased to advise you in this regard. Whether these products may ultimately be used in your food contact application must of course be evaluated by appropriate external experts in this field. Here, too, we will be happy to support you by putting you in touch with the appropriate legal experts and then providing these companies with all the relevant information on our product.
In order to avoid unnecessary costs, we recommend that our customers first test the product in laboratory tests to determine its suitability for the application and its performance.
This approach has already been successfully followed by some of our customers.
NSF certification as per H1 / HX-1
The United States Department of Agriculture (USDA) was responsible for the registration of food compatible lubricants until 1998. Since 1999, “NSF International” (National Sanitary Foundation) and “InS Services Ltd” have taken on this task. In order to be authorized as an acceptable lubricant for the food industry, the requirements of the FDA first have to be met. Lubricants are organized into varying categories depending on conditions and requirements. In this case, H1 lubricants (“Lubricants- General incident contact”) are particularly important as they relate to the food industry.
The highest requirements are set on H1 lubricants. In all situations relating to the food, pharmaceutical, and animal feed industry, where an occasional but technically unavoidable contact can occur between lubricants and products, only H1 certified lubricants are permitted to be used. The ingredients in H1 lubricants have to be HX-1 (“Ingredients for use in H1 lubricants – incidental contact”) certified. In order to be HX-1 certified, substances must either be listed in 21 CFR §178.3570 or have a GRAS notification (Part 182 and 184). Otherwise, a very intense notification process is required
We are pleased to inform you that our product LUBIO® EP 3 has successfully been HX-1 certified following NSF standards. Further information on this can be found in the NSF – White Book™ or the “Regulatory Information Sheet”. Our goal is to have more LUBIO® products certified in the future. We are willing to answer any questions you may have.
How we can support you…
On request, we are also happy to have other products certified by “NSF International” or “InS Services Ltd.” e.g. according to HX-1 – if this is possible. We are happy to support you!
When using lubricants it is usually unavoidable to have substances entering the environment. This especially regards chainsaw oils and loss lubricants, but also includes hydraulic oils, coolant fluids, and materials for many other applications. Thus, particularly in environmentally sensible areas, lubricants and their corresponding additives should exhibit a high level of environmental compatibility.
To provide an opportunity for lubricant users to select environmentally compatible and biodegradable lubricants, ecolabels have been established at a national and an EU-level.
In Germany this is identified as the “Blue Angel”, while on an EU-level it is the EU-Ecolabel, which is also known as the Euroblume, Euro-Margerite, or the EU-Margerite.
When allocating ecolabels, ratings of ecotoxicity, biodegradability and sustainability are the foreground. These ecolabels provide the opportunity for suppliers of lubricants to demonstrate the level of environmental competence of their products, therefore also increasing marketing opportunities of the relevant products.
This is another reason as to why lubricants designated with ecolabels are increasing in product sales in the lubricant industry.
The lubricant substance classification list (LuSc-list) is a list of substances and products which fulfill the relevant criteria of the EU-Ecolabel for lubricants. These criteria were revised upon the EU Commission Decision 2018/1702/EU, from November 8th, 2018. The testing and rating of products is based on their biodegradability, level of aquatic toxicity, and renewability in a competent authority. The release of products is granted through a Letter of Compliance (LoC). We gladly send you this upon request.
The application process for the EU-Ecolabel along with the related decision making process of competent authority, are significantly faster and simplified when using additives in your lubricant formulations which are included in the LuSC-list.
Some of our products, in the acid scavengers (AS), antioxidants (AO), antiwear (AW), extreme pressure (EP), and corrosion inhibitors (CI) sectors, have recently been evaluated by the dutch office SMK and have been added to the LuSC-list. We strive to broaden this product selection for the future.
You can contact us at any time with further question.
RAL-UZ 178 (“The Blue Angel”)
In Germany, the counterpart to the LuSC-list on the EU-level is found in Appendix 1 of the basic criteria RAL-UZ 178 for “Biodegradable lubricants and hydraulic fluids”.
The intention of this list is to simplify Blue Angel registration of products for producers of lubricants and hydraulic fluids, as additional data is not required for products listed in this section.
Testing and rating of products follow similar procedures to that of the EU-Ecolabel and is carried out by the RAL gGmbH. The release of a product is confirmed through a declaration, which we would gladly send you upon request. You can find detailed information on listed products in our Ecolabel-flyer. Feel free to contact us with any further questions.
How we can support you…
We, Schäfer Additivsysteme GmbH, would like to make it easier for our customers to apply for the EU Ecolabel and the “Blue Angel” for lubricants and hydraulic fluids. On request, we are happy to have products included in the LuSC list or Appendix 1 of DE-UZ 178 at the request of the customer – if this is possible. We are happy to support you!